Clinical Specialist Notebook Kit IV

Basic Information

• Brand Name: Clinical Specialist Notebook Kit IV
• Primary DI: 07640168021191
• Version / Model: 02400
• Company Name: Sequana Medical NV, Ghent, Zweigniederlassung Zürich
• Labeler DUNS: 480401893
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-08
• Public Version: 3
• Public Version Date: 2026-02-24
• Public Version Status: Update
• Public Device Record Key: 97646343-a968-4212-8642-5e45ddd7fbd0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDQ	Alfapump System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
65904	Abdominal fluid shunt system programming kit	A collection of devices intended to be used by a clinician to noninvasively adjust the operating parameters of an implanted abdominal fluid shunt pump. It consists of dedicated programming software (e.g., for installation on an off-the-shelf computer), mains power cable, and a USB cable for connection to implant-communicating devices (e.g., charger which wirelessly communicates with the implant). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640168021191	GS1

Premarket Submissions

Submission Number	Supplement Number
P230044	001
P230044	002
P230044	003